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Growing Complexity of Clinical Trials Increases Burden on Investigators and Volunteers, According to Tufts Center for the Study of Drug Development

BOSTON, MA--(Marketwire - January 15, 2008) - More complex clinical trial protocols are
demanding more of investigative site personnel and study volunteers,
leading to longer clinical trials and increasing difficulty in recruiting
and retaining patients, according to a new study recently completed by the
Tufts Center for the Study of Drug Development.

"During the past decade, there has been a steady increase in the number and
frequency of procedures per protocol, and a similar rise in the number of
enrollment eligibility criteria and pages per case report form," said Ken
Getz, a senior research fellow at the Tufts Center and lead investigator on
the study. "These protocol design changes are largely due to the nature of
diseases currently under investigation and intensifying competition among
drug developers."

Getz noted that the increasing complexity of protocol designs is
contributing to the growing time, cost, and risk of drug development. "The
rise in protocol complexity represents a significant challenge for drug
developers," he said.

The Tufts CSDD study is the first ever to quantify the impact of changes in
protocol design on clinical trial performance. Results, reported in the
January/February Tufts CSDD Impact Report, released today, specifically
found that:

-- The annual growth rate of unique procedures per protocol grew 6.5%
between 1999 and 2005.
-- Clinical trials are taking longer: between 1999-02 and 2003-06, total
time from protocol design readiness to database lock rose from 460 to 780
days, or 69.6%.
-- Volunteer enrollment rates dropped from 75% in 1999-02 to 59% in 2003-
06, while volunteer retention rates declined from 69% to 48%.
-- The work effort required of investigative site personnel to administer
clinical study protocols is rising faster than the rate of growth of unique
procedures or their frequency per protocol.

About the Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu)
at Tufts University provides strategic information to help drug developers,
regulators, and policy makers improve the quality and efficiency of
pharmaceutical development, review, and utilization. Tufts CSDD, based in
Boston, conducts a wide range of in-depth analyses on pharmaceutical issues
and hosts symposia, workshops, and public forums, and publishes the Tufts
CSDD Impact Report, a bi-monthly newsletter providing analysis and insight
into critical drug development issues.

Contact Information

Contact:Tufts Center for the Study of Drug DevelopmentCharlene Neu617-636-2187Email Contact